Protocol for the air purification for eosinophilic COPD study (APECS): a randomised controlled trial of home air filtration by HEPA.

Autor:	Saeed MS; Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA., Denoncourt CM; Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA., Chao IA; Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA., Schortmann S; Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA., Nassikas NJ; Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA., Synn AJ; Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA., Koutrakis P; Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA., Coull BA; Department of Biostatistics, Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA., Kang CM; Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA., Wolfson JM; Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA., Ferguson ST; Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA., Rebuli ME; Department of Pediatrics and Curriculum in Toxicology and Environmental Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA., Jaspers I; Department of Pediatrics and Curriculum in Toxicology and Environmental Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA., Liu JP; Institutional Center of Clinical and Translational Research (ICCTR), Biostatistics and Research Design Center (BARD), Boston Children's Hospital, Boston, Massachusetts, USA., Greco KF; Institutional Center of Clinical and Translational Research (ICCTR), Biostatistics and Research Design Center (BARD), Boston Children's Hospital, Boston, Massachusetts, USA., Phipatanakul W; Division of Allergy and Immunology, Boston Children's Hospital, Boston, Massachusetts, USA., Rice MB; Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA mrice1@bidmc.harvard.edu.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Jan 18; Vol. 14 (1), pp. e074655. Date of Electronic Publication: 2024 Jan 18.
DOI:	10.1136/bmjopen-2023-074655
Abstrakt:	Introduction: Exposure to particulate matter (PM) pollution has been associated with lower lung function in adults with chronic obstructive pulmonary disease (COPD). Patients with eosinophilic COPD have been found to have higher levels of airway inflammation, greater responsiveness to anti-inflammatory steroid inhalers and a greater lung function response to PM pollution exposure compared with those with lower eosinophil levels. This study will evaluate if reducing home PM exposure by high-efficiency particulate air (HEPA) air filtration improves respiratory health in eosinophilic COPD. Methods and Analysis: The Air Purification for Eosinophilic COPD Study (APECS) is a double-blinded randomised placebo-controlled trial that will enrol 160 participants with eosinophilic COPD living in the area of Boston, Massachusetts. Real and sham air purifiers will be placed in the bedroom and living rooms of the participants in the intervention and control group, respectively, for 12 months. The primary trial outcome will be the change in forced expiratory volume in 1 s (FEV 1 ). Lung function will be assessed twice preintervention and three times during the intervention phase (at 7 days, 6 months and 12 months postrandomisation). Secondary trial outcomes include changes in (1) health status by St. George's Respiratory Questionnaire; (2) respiratory symptoms by Breathlessness, Cough and Sputum Scale (BCSS); and (3) 6-Minute Walk Test (6MWT). Inflammatory mediators were measured in the nasal epithelial lining fluid (NELF). Indoor PM will be measured in the home for the week preceding each study visit. The data will be analysed to contrast changes in outcomes in the intervention and control groups using a repeated measures framework. Ethics and Dissemination: Ethical approval was obtained from the Institutional Review Board of Beth Israel Deaconess Medical Centre (protocol #2019P0001129). The results of the APECS trial will be presented at scientific conferences and published in peer-reviewed journals. Trial Registration: NCT04252235. Version: October 2023. Competing Interests: Competing interests: MBR, WP, MER, IJ, BAC and PK report research grant funding from the NIH. MBR reports receiving expert testimony fees from the Conservation Law Foundation. BAC and PK report research funding from the US EPA outside the submitted work. WP reports receiving consulting fees from Regeneron, Sanofi, Novartis, Genentech, AstraZeneca and GlaxoSmithKline, all outside the submitted work. No other disclosures were reported. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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